News & Events

ARISE II Data Will Be Submitted to the FDA in Support of Market Clearance for EmboTrap in the U.S.

Galway, Ireland — 21 February 2017 — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced completion of enrollment in the company’s international clinical trial assessing the safety and effectiveness of the EmboTrap®II Revascularization Device, an advanced stent retriever platform for the treatment of acute ischemic stroke.

Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for market clearance of the device in the United States.

The ARISE II study enrolled 228 patients in 19 enrolling sites across the United States and Europe. Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio, is the study’s principal investigator. Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden, is the European principal investigator of the study.

“The value of stent retrievers has been demonstrated by multiple positive trials. Now our focus has moved on to further refinements of mechanical thrombectomy that will yield better patient outcomes,” said Dr. Zaidat. “International cooperation has been excellent. I’m excited to be a part of the process to provide physicians and patients in the United States with access to the latest technology.”

The study enrolled ahead of schedule, with enrollment led by Dr. Hormozd Bozorgchami’s team at Oregon Health Sciences University in Portland and Dr. Marc Ribo’s team at Vall d’Hebron in Barcelona.

“Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial,” said Raul Nogueira, M.D., director of Neuroendovascular Service at Grady Memorial Hospital at Emory University in Atlanta, where the final U.S. patient was enrolled. “As we continue to learn more about the clots that cause stroke, it is important that we have the best tools available to treat those occlusions.”

The EmboTrap platform is designed to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure.

“We’d like to thank the stroke center teams in the United States and Europe for their dedication and commitment to the ARISE II trial. In fully enrolling the ARISE II clinical trial, we are building a strong data set in support of our EmboTrap device as well as adding to the broader pool of stent retriever thrombectomy data for stroke treatment,” said Eamon Brady, Neuravi CEO. “Our vision is to be the therapy leader in acute ischemic stroke intervention and we will to continue to develop innovative therapy solutions to advance patient care.”

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year.

About Neuravi
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s stroke therapy platform, the EmboTrap®II Revascularization Device, is CE marked and commercially available in Europe. The device has been available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

About Neuravi

Led by a team experienced in endovascular device development and global commercialization, the company’s initial technology platform addresses acute ischemic stroke. In collaboration with international researchers and clinicians, the company seeks to develop new understanding that will drive innovative solutions to treat this challenging and devastating disease. In April 2017, Codman Neuro announced the acquisition of Neuravi, leading to the formation of Cerenovus, part of the Johnson and Johnson family of medical device companies.

Team

Contact Us

The EmboTrap® device and EmboTrap®II device are CE-Marked. Caution — Investigational Device. Limited by Federal Law to Investigational Use.

Seán Mac Réamoinn

CFO

Seán is a finance and business leader who has led multiple corporate transactions including mergers, acquisitions, funding rounds and IPOs. Having worked with a range of businesses across the manufacturing, financial and technology sectors, Seán was Head of Finance in the e-business solutions division of Horizon Technology Group plc at a time of rapid growth and during their IPO. He was also a co-founder of mobile technology provider zamano and led it from foundation and ultimately through to a successful listing on the London Stock Exchange.

Justin Lynch

Director

Justin Lynch is a Partner in Fountain Healthcare Partners and also serves as the CFO of the firm. He joined the team in early 2007 prior to the launch of Fund I in 2008. Justin has a BA in Accounting & Finance from Dublin City University, an MBA from Trinity College Dublin and is a member of the Chartered Institute of Management Accountants. He has over 25 years experience in capital markets, corporate finance, entrepreneurial and venture investing across multiple sectors, the latter half in life science. Justin has a particular interest in the medical device sector and leads the firms investments in Neuravi and Vivasure Medical where he also serves as a board member.

Joey Mason

Director

Dr Joey Mason joined Delta Partners in 2003, specialising in Life Science investments. His current focus is on medical technologies and Health IT. He serves on the boards of Genable Ltd, Glysure Ltd, Miracor Medical Systems GmbH, SpineGuard SA, Accunostics Ltd and Neuravi Ltd. He acts as an observer on the board of QStream, Inc. and previously served on the board of Heartscape Technologies, Inc., prior to its sale.

Joey serves on the board of EVCA (the European Private Equity and Venture Capital Association) and on its constituent Venture Capital platform.

Having trained as a doctor at Trinity College, Dublin, Joey spent five years as an investment banker in the Health Care sector with Morgan Stanley International and Technomark in London. From 1995 until 1999 he was Director of Corporate Development at Biotrin Holdings plc, an Irish immuno-diagnostics company specialising in infectious diseases and organ damage and backed by Delta Partners and other leading international VCs.

In 2000 he co-founded and managed Eumom Ltd, a marketing services business operating websites for pregnant women in Germany, Ireland, Switzerland and the UK.

Chloe Brown

Director Market Development

Chloe has 10 years experience in interventional neurovascular sales and marketing, launching several game-changing technologies including Onyx, Pipeline and Solitaire FR. Most recently, Chloe led the European Marketing and Market Development Activities in Acute Ischemic Stroke for Covidien. Chloe developed the Stroke Centre of Excellence Programs with 5 key Stroke Institutions across Europe which trained over 400 physicians. Chloe was instrumental in developing partnerships between Covidien and both the European and World Stroke Organisations.

Jill Amstutz

VP Global Marketing

With over 20 years of experience in the medical device industry, Jill leverages strategic marketing skills as a collaborative project leader for early stage medical device companies. She guided market-focused product development of neurointerventional stroke therapies at Micrus Endovascular and Guidant Compass. Part of the early team at Sadra Medical, which was acquired by Boston Scientific, she played a leadership role in developing Lotus University. Jill has an MBA from the Stanford GSB and a BA from Princeton University.

Paul Geudens

VP EMEA Sales and Marketing

Paul is a successful leader within the medical device industry having run sales and marketing organizations in both startup and Fortune 100 companies. Most recently, Paul led the market entry efforts for Surpass Medical, which was later acquired by Stryker for $135M in 2012, served as VP of Sales and Marketing for Stentys, and acted as Executive VP of Operations at Caliber Therapeutics. Prior to his startup endeavors, Paul spent 12 years with Johnson & Johnson in senior leadership positions across the company’s cardiovascular franchise.

Michael Gilvarry

VP of R&D and Technical Operations

An experienced R&D leader, Michael has worked in the medical device industry for over 15 years. Prior to joining the Neuravi team, he was an R&D Manager at Abbott Vascular where he successfully led the development of the EmboShield NAV6 Embolic Protection System and played a key role in the US launch of the Xact Carotid Stent. He is a named inventor on over 40 US patents, granted or pending.